NCT03200366

Comparing Interventions to Increase Colorectal Cancer Screening

Completed NA Results posted Last updated 13 September 2021

What this trial tests

NA trial testing Tailored DVD in Colorectal Cancer in 371 participants. Completed in 21 October 2020.

Timeline

26 July 2017

Primary endpoint
21 October 2020

21 October 2020

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	371
Start date	26 July 2017
Primary completion	21 October 2020
Estimated completion	21 October 2020
Sites	2 locations across United States

Drugs / interventions tested

• Tailored DVD
• Patient Navigation

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Indiana University

Who can join

Adults 45 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants Completing CRC Screening Per Electronic Medical Record Documentation Primary · 12 months post-baseline interview

Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.

Group	Value	95% CI
Tailored DVD	37
Tailored DVD + Patient Navigation	59
Usual Care	27

Participants Completing Colonoscopy Per Electronic Medical Record Documentation Secondary · 12 months post-baseline interview

Number of participants completing a colonoscopy is measured by electronic medical record review (EMR). Dates that participants completed a colonoscopy are extracted from the EMR.

Group	Value	95% CI
Tailored DVD	24
Tailored DVD + Patient Navigation	46
Usual Care	20

Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale Secondary · 12 months post-baseline interview

Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS). BBPS scores the total quality on a 10 point scale from 0-9. Higher scores indicate better quality of bowel preparation.

Group	Value	95% CI
Tailored DVD	7.13	± 1.90
Tailored DVD + Patient Navigation	6.59	± 2.40
Usual Care	7.05	± 2.44

Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale Secondary · 12 months post-baseline interview

Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale. The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor. Some endoscopists choose to grade quality more generally as adequate vs. inadequate. To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings). Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is score

Group	Value	95% CI
Tailored DVD	22
Tailored DVD + Patient Navigation	39
Usual Care	18

Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy Secondary · 12 months post-baseline interview

Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety.

Group	Value	95% CI
Tailored DVD	2.46	± 0.78
Tailored DVD + Patient Navigation	2.23	± 0.67
Usual Care	2.28	± 0.76

Satisfaction With Colonoscopy Experience Secondary · 12 months post-baseline interview

Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team. Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied. Scores range from 1 to 4 with higher scores indicating greater satisfaction.

Group	Value	95% CI
Tailored DVD	3.38	± 0.96
Tailored DVD + Patient Navigation	3.60	± 0.78
Usual Care	3.13	± 1.06

Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation Secondary · 12 months post-baseline interview

Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR.

Group	Value	95% CI
Tailored DVD	15
Tailored DVD + Patient Navigation	13
Usual Care	8

Participants Who Self-Reported Completing CRC Screening Secondary · 6-9 months post-baseline interview

Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview.

Group	Value	95% CI
Tailored DVD	48
Tailored DVD + Patient Navigation	59
Usual Care	43

Participants Who Self-Reported Completing a Colonoscopy Secondary · 6-9 months post-baseline interview

Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview.

Group	Value	95% CI
Tailored DVD	26
Tailored DVD + Patient Navigation	46
Usual Care	27

Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT) Secondary · 6-9 months post-baseline interview

Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview.

Group	Value	95% CI
Tailored DVD	34
Tailored DVD + Patient Navigation	28
Usual Care	20

Change in Knowledge of CRC and Screening Secondary · 6 months post-baseline interview

Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests. The mean of the 9 items is calculated at baseline and 6 months post-baseline. Change from baseline equals the mean at 6 months minus the mean at baseline. Change can range from -9 to 9 with positive values indicating an increase in knowledge.

Group	Value	95% CI
Tailored DVD	1.14	± 0.24
Tailored DVD + Patient Navigation	1.32	± 0.25
Usual Care	0.75	± 0.23

Change in Perceived Risk for CRC Secondary · 6 months post-baseline interview

Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely). Higher scores indicate a higher perceived risk for getting CRC. The mean of the 3 items is calculated at baseline and 6 months. Change in perceived risk equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating

Group	Value	95% CI
Tailored DVD	0.23	± 0.11
Tailored DVD + Patient Navigation	0.03	± 0.11
Usual Care	0.18	± 0.11

Sponsor's own description

The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.

The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patient Navigation Plus Tailored Digital Video Disc Increases Colorectal Cancer Screening Among Low-Income and Minority Patients Who Did Not Attend a Scheduled Screening Colonoscopy: A Randomized Trial.
   Rawl SM, Perkins SM, Tong Y, Katz ML, et al · · 2024 · cited 6× · PMID 38470961 · DOI 10.1093/abm/kaae013